Research Title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (RAVEN)
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Robert Stoltz, M.D., Ph.D.
Description: Following a 4-week maximum screening period, patients will be randomized and treated for approximately 76 weeks. Treatment visits will be scheduled in 4-week intervals. After 6 initial monthly injections of brolucizumab or aflibercept (loading phase), subjects will enter a one-year individualized flexible treatment (IFT) phase. During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an active or a sham injection. Treatment with active will be interrupted when disease stability is reached. Maximum study duration per patient is 80 weeks.
Start Date: October 2019
Recruitment: Enrolling
Project Personnel: Leslie Marcus, CCRC; Caitlin Harrison, CCRC, COA; Stephanie Campbell, CRC, COA; Amber Adams, CRC, COA
Location(s): Marietta; 833 Campbell Hill Street, Suite 300, Marietta, GA 30060
Clinical Trial Team
Active Trials
Past Trials
- AART C-02-60
- Acucela 4429-202 SEATTLE
- Aerpio AKB-9778-CI-5001 TIME-2b
- Allergan 150998-005 CEDAR
- Allergan 1771-201-008 MAPLE
- Allergan 190342-038 BEACON
- ALLERGAN 206207-012
- AREDS2
- AREDS2 ForeseeHome
- Blair Symington
- C-09-067 RACE
- DRCR.net Protocol N
- Gemini GEM-NH-002 Clarity 2
- Genentech GR39821
- Graybug GBV-102-002 Altissimo
- HORIZON FVF3426g
- KalVista KVD011-201
- LFG316A2203
- MARINA FVF2598g
- Novartis CSPP100A2244
- Ocriplasmin Research to Better Inform Treatment (ORBIT)
- OPH1002
- OPH1004
- Ophthotech OPH2003
- PDEX
- Regeneron R2176-3-AMD-1417 CAPELLA
- Regeneron R910-3-AMD-1517 ONYX
- Regeneron R910-3-DME-1518 RUBY
- Regeneron VGFTe-OD-1411 PANORAMA
- RIDE FVF4168g
- RISE FVF4170g
- Roche BP 30099 BOULEVARD
- Roche BP29647 AVENUE
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- Roche GX30191 OMASPECT
- SAILOR FVF3689g
- SCORE
- SCORE2
- Shelby Satterwhite
- Suprachoroidal Buckling for Retinal Detachment
- Taiwan Liposome Company (TLC) TLC399A2002
- Xcenda C-01-17 ForeseeHome